Jobs at ClinChoice

Leads North American regulatory affairs for pharmaceutical and biotech clients, developing global regulatory strategies, overseeing submissions, ensuring compliance, advising on FDA and health authority requirements, and managing regulatory projects. The role includes authoring and compiling IND, CTA, BLA, MAA, and NDA documents, monitoring regulatory changes, mentoring and hiring staff, supporting client presentations, and contributing to department growth and digital process solutions.

Supports clinical trial statistical programming under senior guidance, including developing and validating datasets, tables, figures, listings, and CDISC-compliant regulatory submission deliverables. Uses SAS and/or R to process clinical data, contribute to SDTM and ADaM datasets, maintain specifications and documentation, perform quality checks, and resolve programming issues. Collaborates with biostatisticians, data managers, and cross-functional teams while developing expertise in clinical research standards and statistical programming.

Leads clinical pharmacology and PK/PD study design, protocol development, modeling and simulation, data analysis, regulatory reporting, and client collaboration. Uses pharmacokinetic software to support clinical trials, publications, and regulatory submissions. Provides scientific leadership, mentors junior pharmacologists, manages multiple projects, and applies current clinical pharmacology practices across pharmaceutical and biotechnology programs.

Supports clinical trial statistical activities under senior guidance, including study design and analysis, statistical analysis plans, tables, listings, figures, data checks, clinical study reports, documentation, and statistical programming collaboration. Works with cross-functional clinical research teams while following SOPs, regulatory requirements, and applicable standards such as CDISC, SDTM, and ADaM.

Leads statistical programming activities for clinical trials, including programming and validating datasets, tables, figures, listings, and electronic submissions. Oversees CRO and vendor deliverables, supports CDISC-compliant submissions, contributes to clinical documentation and standards, performs exploratory analyses, and provides technical guidance to programmers. Collaborates with cross-functional teams to ensure high-quality, timely deliverables.

Manages multiple clinical trials through site selection, study start-up, monitoring, data verification, safety reporting, site closeout, and regulatory compliance. Trains site staff, oversees investigational products and study documentation, supports submissions and CRF development, resolves data queries, and supervises junior CRAs. The role focuses on oncology and medical device trials, including gastrointestinal oncology and HIFU therapy, with both remote and on-site monitoring.

Leads and supports statistical programming for clinical studies within a CRO environment. Implements protocol and clinical development programming, prepares specifications and documentation, ensures quality and regulatory compliance, supports standards and automation, coordinates team activities, escalates risks, and collaborates with statisticians, programmers, data managers, and study leaders.

Manage 2-3 clinical trials with site start-up, on-site and remote monitoring, SDV, CRF review, safety reporting, investigational product and trial material management, study closeout, site training, and supervision/mentoring of junior CRAs. Support submissions, CRF design, and quality control for oncology and complex trials.

Leads and supports statistical programming deliveries for oncology clinical studies, implementing protocol and clinical development programming, producing compliant documentation, ensuring quality and standards adherence, managing concurrent activities, and coordinating with statisticians, programmers, data managers, and study leaders. The role independently delivers high-quality programming, escalates risks, supports team planning, and contributes to process improvements within a CRO client-facing environment.

Leads statistical activities for oncology clinical trials, serving as lead statistician for study strategy and deliverables. Authors and reviews Statistical Analysis Plans, Analysis Database Specifications, and statistical sections of clinical study reports. Interprets analysis outputs, ensures regulatory compliance, collaborates with clinical, programming, data management, and regulatory teams, and guides statistical programmers. Communicates statistical results and risks to technical and non-technical stakeholders.

Lead statistical strategy and deliverables for clinical trials (primarily immunology), author and review SAPs and ADS, interpret analysis outputs, ensure regulatory compliance, collaborate with clinical, programming, data management and regulatory teams, oversee/mentor statisticians and programmers.

Lead and deliver clinical trial data management activities including database setup, eCRF specification, edit checks, testing, data review/reconciliation, database lock/unlock, SAE reconciliation, vendor/data transfers, team training, and oversight to ensure timelines and quality.

Develop and validate SDTM and ADaM datasets using R per CDISC standards, support TLF generation in R or SAS, perform QC and reconcile data issues, collaborate with biostatistics and clinical teams, and contribute to automation and reproducible workflows for regulatory submissions.

Lead design and execution of statistical analysis plans for large RWE studies; mentor junior analysts; build automated RWD workflows and advanced analytics/ML solutions; create dashboards and visualizations; advise clients on results and guide cross-functional integration of multiple data sources while improving methodologies and standards.

Develop and validate SDTM and ADaM datasets using R per CDISC standards, support TLF generation in R/SAS, perform QC and reconciliation, collaborate with statisticians and data teams, contribute to automation, documentation, and version control.

The Business Development Director is responsible for driving growth by securing new clients and expanding services, managing the full sales lifecycle, and maintaining relationships with key stakeholders in the life-sciences industry.